GEN1046 Safety Trial in Patients With Malignant Solid Tumors

  • End date
    Dec 26, 2023
  • participants needed
  • sponsor
Updated on 26 March 2022
renal function
measurable disease
kidney function tests
solid tumour
solid tumor
squamous cell carcinoma of head and neck
renal function test
stage iv non-small cell lung cancer
kidney function test


The purpose of the trial is to evaluate the safety of GEN1046 as monotherapy and in combination therapies in patients with malignant solid tumors


The trial is an open-label, multi-center safety trial of GEN1046. The trial consists of two parts, a dose escalation part (phase 1, first-in-human (FIH) and an expansion part (phase 2a)). The expansion part of the trial will be initiated once the Recommended Phase 2 Dose (RP2D) has been determined.

Condition Solid Tumors, Non-small Cell Lung Cancer, Urothelial Carcinoma, Endometrial Carcinoma, Triple Negative Breast Cancer, Squamous Cell Carcinoma of the Head and Neck, Cervical Cancer
Treatment GEN1046, GEN1046 in combination with docetaxel (in a single expansion cohort), GEN1046 in combination with pembrolizumab (in a separate expansion cohort)
Clinical Study IdentifierNCT03917381
Last Modified on26 March 2022


Yes No Not Sure

Inclusion Criteria

For Dose Escalation
• Have a histologically or cytologically confirmed non-CNS solid tumor that is metastatic
or unresectable and for whom there is no available standard therapy
For Expansion
• Have histologically or cytological confirmed diagnosis of relapsed or refractory
advanced and/or metastatic NSCLC, EC, UC, TNBC, SCCHN, or cervical cancer who are not
anymore candidates for standard therapy For two separate expansion cohorts: metastatic
NSCLC without prior systemic treatment regimens for metastatic disease
For Both Dose Escalation and Expansion
Have measurable disease according to RECIST 1.1
Have Eastern Cooperative Oncology Group (ECOG) 0-1
Have an acceptable hematological status
Have acceptable liver function
Have an acceptable coagulation status
Have acceptable renal function

Exclusion Criteria

Have uncontrolled intercurrent illness, including but not limited to
Ongoing or active infection requiring intravenous treatment with antiinfective
Ongoing or recent evidence of autoimmune disease
Symptomatic congestive heart failure (Grade III or IV as classified by the New
History of irAEs that led to prior checkpoint treatment discontinuation
York Heart Association), unstable angina pectoris or cardiac arrhythmia
Uncontrolled hypertension defined as systolic blood pressure ≥ 160 mmHg and/or
diastolic blood pressure ≥ 100 mmHg, despite optimal medical management
History of chronic liver disease or evidence of hepatic cirrhosis
Serious, non-healing wound, skin ulcer (of any grade), or bone fracture
Prior history of myositis, Guillain-Barré syndrome, or myasthenia gravis of any
Prior therapy
History of non-infectious pneumonitis that has required steroids or currently has
Toxicities from previous anti-cancer therapies that have not adequately resolved
History of organ allograft (except for corneal transplant) or autologous or
allogeneic bone marrow transplant, or stem cell rescue within 3 months prior to
the first dose of GEN1046
Any history of intracerebral arteriovenous malformation, cerebral aneurysm, new
(younger than 6 months) or progressive brain metastases or stroke
Radiotherapy: Radiotherapy within 14 days prior to first GEN1046 administration
Palliative radiotherapy will be allowed
Treatment with an anti-cancer agent (within 28 days or after at least 5
half-lives of the drug, whichever is shorter), prior to GEN1046 administration
Accepted exceptions are bisphosphonates (e.g., pamidronate, zoledronic acid
etc.) and denosumab
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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